MDMA Clinical Trials

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Posted on Dec 03, 2018, 8 p.m.

5 US sites are now enrolling volunteers for MDMA assisted psychotherapy clinical trials, with 9 more enrolling participants soon, making the idea of MDMA moving from out of nightclubs into doctor’s offices a possibility.

Multidisciplinary Association for Psychedelic Studies is a nonprofit organization focused on researching medical benefits of psychedelics and marijuana which has announced that it is beginning to recruit volunteers for Phase 3 clinical trials to investigate whether MDMA/ecstasy may be of benefit as a treatment for PTSD.

This psychotherapy is unique among trauma treatments by allowing patients to access trauma in a way they don’t become overwhelmed by past experiences so they can address their fears around their traumas.

MAPS will be enrolling volunteers for these trials at 5 sites in: Boulder, Colorado; Fort Collins, Colorado; North Hollywood, California; Mount Pleasant, South Carolina; and New Orleans, Louisiana. There are plans are to enroll between 100-150 adults volunteers with severe PTSD in these trials who need to live near one of the locations, and meet other specific requirements. There will be 14 sites in total including the 5 listed and 9 other sites to start enrollment soon in: San Francisco, California; Boston, Massachusetts; New York, New York; Vancouver, British Columbia; Montreal, Quebec; Be’er Ya’akov, and Sheba/Tel Hashomer, Israel. Results from this Phase 3 trial will be review before beginning a second Phase 3 trial which will enroll another 100-150 volunteers.

Volunteers will undergo a 12 week treatment plan consisting of 15 sessions which will include 3 experimental sessions during which some will receive either a placebo or MDMA assisted psychotherapy.

Phase 3 trials are the final stage before the finish line where the US Food and Drug Administration can clear/approve a drug for medical use. If these trials produce positive results the next step may be FDA approval of MDMA assisted psychotherapy treatment for PTSD.

Multidisciplinary Association for Psychedelic Studies believes that approval could happen as soon as 2021, if it does it could be life changing for the estimated 10 million Americans with PTSD.